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Ramucirumab for Thymic Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Swedish Cancer Institute-Edmonds, Edmonds, WAThymic Carcinoma+3 MoreRamucirumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests how well carboplatin and paclitaxel work with or without ramucirumab to treat patients with thymic cancer that has spread or returned.

Eligible Conditions
  • Unresectable Thymic Carcinoma
  • Thymic Carcinoma
  • Metastatic Thymic Carcinoma
  • Recurrent Thymic Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
nab-paclitaxel
1
Ipatasertib
1
Treatment (pembrolizumab)

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 2 years

Year 2
Progression-free survival
Up to 2 years
Disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease)
Incidence of adverse events
Overall survival
Response rate (complete response, partial response, confirmed and unconfirmed)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
nab-paclitaxel
1
Ipatasertib
1
Treatment (pembrolizumab)

Side Effects for

Ramucirumab and Docetaxel
46%Fatigue
36%Neutropenia
32%Diarrhoea
30%Decreased appetite
27%Nausea
26%Alopecia
24%Dyspnoea
23%Stomatitis
22%Cough
22%Anaemia
19%Epistaxis
18%Neutrophil count decreased
17%Constipation
17%Oedema peripheral
16%Pyrexia
16%Mucosal inflammation
14%Febrile neutropenia
14%Vomiting
14%Lacrimation increased
13%Myalgia
13%Leukopenia
12%Peripheral sensory neuropathy
12%Back pain
11%Dysgeusia
11%Weight decreased
11%Hypertension
11%Headache
11%Insomnia
11%Arthralgia
11%Asthenia
9%Abdominal pain
9%White blood cell count decreased
8%Oropharyngeal pain
8%Pain in extremity
8%Thrombocytopenia
7%Nail discolouration
7%Rash
7%Dizziness
6%Dyspepsia
6%Productive cough
6%Haemoptysis
6%Paraesthesia
6%Dysphonia
6%Pneumonia
6%Pain
6%Platelet count decreased
6%Hyperglycaemia
6%Dehydration
5%Bone pain
1%Atrial fibrillation
1%Lobar pneumonia
1%Pneumothorax
1%Chronic obstructive pulmonary disease
1%General physical health deterioration
1%Metastatic pain
1%Death
1%Hyponatraemia
1%Syncope
1%Confusional state
1%Renal failure acute
1%Pleural effusion
1%Pulmonary embolism
1%Pulmonary haemorrhage
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT01168973) in the Ramucirumab and Docetaxel ARM group. Side effects include: Fatigue with 46%, Neutropenia with 36%, Diarrhoea with 32%, Decreased appetite with 30%, Nausea with 27%.

Trial Design

2 Treatment Groups

Arm B (carboplatin, paclitaxel)
1 of 2
Arm A (ramucirumab, carboplatin, paclitaxel)
1 of 2

Active Control

Experimental Treatment

66 Total Participants · 2 Treatment Groups

Primary Treatment: Ramucirumab · No Placebo Group · Phase 2

Arm A (ramucirumab, carboplatin, paclitaxel)Experimental Group · 3 Interventions: Carboplatin, Paclitaxel, Ramucirumab · Intervention Types: Drug, Drug, Biological
Arm B (carboplatin, paclitaxel)ActiveComparator Group · 2 Interventions: Carboplatin, Paclitaxel · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Paclitaxel
FDA approved
Lexatumumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
387 Previous Clinical Trials
262,887 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,165 Previous Clinical Trials
41,167,375 Total Patients Enrolled
10 Trials studying Thymic Carcinoma
833 Patients Enrolled for Thymic Carcinoma
Anne S TsaoPrincipal InvestigatorSouthwest Oncology Group
5 Previous Clinical Trials
258 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 33 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You cannot receive radiation therapy as a potential cure for your condition. You can participate if you had radiation therapy in the past for pain relief, as long as it's been at least 7 days since your last treatment and you've recovered from any side effects.
You cannot have surgery to treat your condition.
If you have recurrent thymic carcinoma that cannot be surgically removed, you may have had chemotherapy in the past as long as it was more than 6 months before the study.
You will be asked if you want to save samples of your blood or other tissues for future research.
You have thymic carcinoma that cannot be removed by surgery and it has spread to other parts of your body or has come back after initial treatment.
References

Frequently Asked Questions

What conditions is Ramucirumab typically prescribed to treat?

"Ramucirumab is the treatment of choice for advanced endometrial cancer, but can also prove effective against melanoma metastasis, lymphoma non-Hodgkin's, and other neoplasms." - Anonymous Online Contributor

Unverified Answer

What level of risk do patients encounter when taking Ramucirumab?

"The risk associated with Ramucirumab has been estimated at a 2 due to the presence of clinical data that vouch for its safety, though efficacy is yet to be confirmed." - Anonymous Online Contributor

Unverified Answer

How many individuals have agreed to participate in this trial thus far?

"Affirmative. Information on clinicaltrials.gov demonstrates that this research project, which was published on August 9th 2018, is actively recruiting patients. Approximately 66 subjects must be enrolled from across 100 distinct locations." - Anonymous Online Contributor

Unverified Answer

Are there still opportunities to volunteer for this research endeavor?

"Affirmative, according to clinicaltrials.gov this study is petitioning for participants which was first advertised on August 9th 2018 and updated lastly on January 6th 2022. The trial demands the recruitment of 66 individuals from 100 distinct sites." - Anonymous Online Contributor

Unverified Answer

How many healthcare facilities in the state are conducting this clinical experiment?

"Participants of this clinical trial can be recruited from City of Hope South Pasadena in Southern California, Southwest Oncology PC located in Durango, Idaho, and the City of Hope West Covina situated in Alaska. Additionally, there are 100 other locations across the nation." - Anonymous Online Contributor

Unverified Answer

Have there been any previous inquiries into Ramucirumab's efficacy?

"At the moment, 1202 clinical trials are in progress to investigate Ramucirumab with 336 of those at Phase 3. Shanghai is a major hub for research into this medication; however, there are 68186 medical institutions conducting various experiments across the world." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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